BD (Becton, Dickinson and Company) RA Principal Medical Writer (Remote Opportunity) in Warwick, Rhode Island
Job Description Summary
The Principal Medical Writer is the subject matter expert in writing and editing complex clinical and scientific reports including summaries of data analyzed and provided by the Medical Writing Analyst Group for submission to regulatory agencies for in company use. May supervise/act as project manager and provide comprehensive literature reviews, exhibits and other projects requiring the skill in medical communication. Coordinate the completion of writing Clinical Evaluation Plans (CEPs), Literature Search Protocols (LSP)Clinical Evaluation Reports (CERs both for EU and Global submissions) and Summary of Safety and Clinical Performance (SSCPs) for all BDI Surgery product lines. Will coordinate and complete any additional medical writing assignment as necessary.
Essential Duties and Position Responsibilities
Responsible for leading and ensuring completion of all Medical Writing Projectsontime
May supervise Medical Writing staff includingreviewing work products,managing performance, coaching, training and development
Preparing, writing,andeditingcomplex regulatory/non-regulatorydocuments andprovideresponseto regulatory authorities (e.g.Notified Bodies, FDA,etc.) Efforts will center around Clinical Evaluationplans andreports (CEP/CERs) to support both European Union and Globalsubmissions, SSCPsand clinical data reports/summaries in support of all BDI Surgery products
Collaborates withcross functional teamsincluding butnot limited to product development, RA Specialists, Medical Affairs, R&D, PMS Group and Quality to create new or update existing CERs, SSCPs, reports to support expansion of indication/claims. This includes critical reviews and incorporation of data frompublishedunpublished and historical clinical evaluations
Participates in post-market surveillance activitiessuch as PMS meetings, and providing results from systematic literature reviews
Collaborates withAnalystGroup toincorporate tables, figures,charts,and referencesfor the creation/updating of largecomplextechnical/clinical documents
Provides expert guidance to ensure documents are produced in accordance with corporate/BU procedures and external guidelines
Provides expert guidance toensure documents are producedin accordance with regulatory standard/guidance and regulations
Provides coaching, mentorship to junior and senior medical writers
Qualifications, Knowledge, and Skills Required:
10years’ experiencewith B.S. degree or7years’ experiencewithmaster’s degreeor5years’ experiencewith PhD in preparing, creating, updating regulatory documents. Extensive experience with creating/ writing Clinical EvaluationReports frombeginning to end is required.
Minimum3years' experiencewithsupervising a high producing team
Extensive experience with implantable surgical medical products or related industries
Working knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices
Extensive experience in Microsoft Word, Excel andPowerPoint
Excellent English Language skills, especially in writing and proof reading
Clinical or scientificresearch background required
Extensive knowledge with EU MDR, MEDDEV 2.7.1 Rev 4, GSPR, and IMDRF required
Excellent understanding of scientific or clinical research and methods required
Strong oral and written communication skills
Excellent interpersonal skills
Must be able to handle a variety of projects at the same time
Strong prioritization skills required
Ability to motivate andempowerdiverse team
Have an inclusive mindset in working with others
Ability for potential travel (up to 10%)
Regulatory Affairs Specialist
External Relationships :
Corporate Legal and Regulatory Affairs
Notified Bodies, and regulatory agencies (i.e.FDA)
Scope and Impact of Position:
This key position willensuregenerationandmaintenance ofclinical evidenceto support regulatory submissionforall BDI Surgical Business Unitproducts. This includes a growingline of mesh prosthetics, biologicimplants, fixationsystems, andsurgical instrumentsto complement innovative techniques forvarious surgical procedures.In addition to this extensive suite of products, theBiosurgeryfranchise is deliveringa growingline of enhanced sealants and hemostatic products to complement surgical techniques across,thoracic,cardiovascular,and other surgical specialties.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA RI - Warwick
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.